Emerging markets are no more an option, but a strategic imperative for global
India is one of the fastest growing clinical research destination with a growth rate
2-1/2 times the overall market growth.
As the world?s third largest producer of drugs by volume, with drug research and
development work force, india is a major player in the pharmaceutical industry.
India has over 100 fda approved manufacturing units. India has fi
led the maximum
number of andas in the us almost equivalent or more than the number of andas
led by us companies.
Indias clinical research landscape is undergoing a glorious metamorphosis, aided
by uniquely diff
erentiating capabilities, a rapidly transforming health care market
and an enabling environment i.e rapidly adopting itself to global standards.
India?s strength in formulation development, new drug delivery system and
backed by excellent chemistry and bio analytical technics has brought down cost
of bio equivalence studies dramatically and without compromising international
India is rated as one of the most attractive destinations for clinical trials and bio
equivalence studies by various surveys.
India?s capability in bio equivalence has evolved with exceptionally good knowledge,
highly trained and skilled technical man power in bio analytical services including
method development validation and sample processing with strict adherence to
cfr part xi.
Huge volunteer data base, experience & knowledgable ethics committee, new
schedule y of the regulators enables compliance with global regulations.
I had an opportunity to audit one of the leading ba/be centres in india namely,
quest life sciences pvt.ltd
is centre is audited and approved by usfda having 100 beds clinical facility and a
good bio analytical laboratory, has fi
led over 30 andas in the us.
ey have a volunteer data base over 3000 subjects and in addition over 800 post
menopausal women subjects.
e company has even conducted bio equivalence studies on cancer patients.
ese studies have been fi
led in the us besides european regulatory requirements.
ey have faced innumerable audits from international clients, mainly from the
us and europe.
I was surprised to fi
nd that the cost of the ba/be studies in india is less than half
of the study conducted in the us besides study schedules is one of the fastest as
compared to many other centres outside india.
Quest has made a couple of para iv fi
A slide show of one of the facilities is available on request
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